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Sponsored by: |
CuraGen Corporation |
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Information provided by: | CuraGen Corporation |
ClinicalTrials.gov Identifier: | NCT00323518 |
CG53135-05 (velafermin), a recombinant human fibroblast growth factor-20 (rhFGF-20) protein, is under investigation for the prevention of oral mucositis.
Oral mucositis is a commonly occurring side effect of high-dose chemotherapy in patients undergoing autologous hematopoietic stem cell transplant. The objective of this Phase II trial is to confirm the safety and efficacy of CG53135-05 (velafermin) when administered as a single dose to patients at risk for developing oral mucositis.
Condition | Intervention | Phase |
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Oral Mucositis Stomatitis |
Drug: velafermin Drug: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Randomized Double Blind Placebo Controlled Trial to Assess Safety and Efficacy of Velafermin for Prevention of Oral Mucositis in Hematologic Cancer Patients Receiving Autologous Stem Cell Transplant |
Enrollment: | 390 |
Study Start Date: | May 2006 |
Study Completion Date: | August 2008 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator
placebo
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Drug: placebo
administered intravenously as 100mL single dose over 15 minutes on day 1
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2: Experimental
30 mcg/kg velafermin
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Drug: velafermin
administered intravenously as 100mL single dose over 15 minutes on day 1
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3: Experimental
10 mcg/kg velafermin
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Drug: velafermin
administered intravenously as 100mL single dose over 15 minutes on day 1
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4: Experimental
60 mcg/kg velafermin
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Drug: velafermin
administered intravenously as 100mL single dose over 15 minutes on day 1
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | CuraGen Corporation ( Vice President, Regulatory Affairs and Quality Assurance ) |
Study ID Numbers: | CG53135-CLN-12 |
Study First Received: | May 8, 2006 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00323518 History of Changes |
Health Authority: | United States: Food and Drug Administration |
oral mucositis hematologic autologous stem cell transplant velafermin |
stomatitis oncology - supportive care mouth diseases |
Mouth Diseases Digestive System Diseases Stomatitis Mucositis |
Hematologic Neoplasms Gastrointestinal Diseases Stomatognathic Diseases Gastroenteritis |
Mouth Diseases Digestive System Diseases Mucositis Stomatitis |
Gastrointestinal Diseases Stomatognathic Diseases Gastroenteritis |